MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000A PLATFORM SYSTEM

Model Number	EV1000A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history review was completed and all inspections passed with no non-conformances.
Event or Problem Description
It was reported in the ev1000 system that when clearsight starts the system gets to a good physiocal continues for a while and then completely stops reading and begins to recalibrate.It acted as if the cuff was leaking but they switched out several cuffs and had the same occurrence.They also reported the blood pressures being very off.The inaccurate values were in comparison to a brachial cuff.The maps were off by more than 20mmhg thus making sys and dia even further apart.Clearsight was reading clinically low while the cuff was normal.There were no clinical signs for hypotension.This was during use.There is no patient injury.Patient demographics were requested but unavailable.
Additional Manufacturer Narrative
One ev1000 device was received for product evaluation.A visual inspection did not find any visible physical damage.The panel and data box booted up and connected on both panel ethernet ports without issue.The touch screen is functional.The data box passed functional test.The system was connected to a mini-sim.Ap and cvp waveforms were able to be zeroed and were stable for half an hour as was the bt.There was no defect found in the unit.

• Brand Name: EV1000A PLATFORM SYSTEM
• Common Device Name: EV1000A PLATFORM SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14092334
• Report Number: 2015691-2022-05031
• Device Sequence Number: 4775864
• Product Code: DXG
• UDI-Device Identifier: 00690103189650
• UDI-Public: (01)00690103189650(11)181119
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K100709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2023
• Device Model Number: EV1000A
• Device Catalogue Number: EV1000A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown